(101 days)
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
The NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec nominal) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. NeuroStar TMS Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers NeuroStar TMS Therapy®. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. The SenStar Connect is a non-sterile, multi-use consumable which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment and provides surface field cancellation to reduce stimulation of the scalp. The TMS TrakStar™ practice data management system consists of a standalone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.
The provided text is a 510(k) summary for the NeuroStar® TMS Therapy System. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria, specifically in the context of clinical performance or diagnostic accuracy relevant to AI/algorithm performance.
The document primarily focuses on engineering and performance specifications related to the physical function of the TMS device and its safety (electrical safety, EMC). It highlights that the 3.0 version of the device has "enhanced thermal performance," "improved ergonomics and reliability," and "improved user work flow" compared to the predicate device.
Therefore, I cannot fulfill the request as it asks for information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) that is not present in the provided text. The text does not describe an AI/algorithmic medical device in the way implied by the questions regarding acceptance criteria for clinical performance, ground truth, expert consensus, or comparative effectiveness studies with human readers.
The available information is limited to:
- Device Performance Specifications Table: This table compares physical and operational characteristics of the device (like treatment level range, pulses per second, coil type, etc.) between the predicate and the new device. These are engineering specifications, not clinical performance metrics related to diagnostic accuracy.
- Bench Performance Testing: This section lists tests performed to demonstrate the substantial equivalence of the new device to the predicate in terms of physical characteristics (magnetic field mapping, coil positioning accuracy) and safety (electrical safety, EMC). It explicitly states that "Verification and validation testing demonstrated that the changes to NeuroStar 3.0 do not substantially modify the performance of the device," implying the performance remains similar to the predicate.
To answer your specific questions, I would need a different type of document, such as a clinical study report or a 510(k) summary that details the clinical performance and validation of an AI-driven medical device.
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.